Gilotrif

"Jan. 13, 2015 -- Drug-maker Bristol-Myers Squibb says a trial of nivolumab (Opdivo) has been stopped early because the drug improves how long people with a type of advanced lung cancer live compared to chemotherapy.

Prescribing Information

Gilotrif (afatinib) a tyrosine kinase inhibitor used to treat non-small cell lung cancer (NSCLC) that has spread (metastasized), whose tumors have a genetic mutation called epidermal growth factor receptor (EGFR). Common side effects include diarrhea, rash, blisters or other skin lesions, inflammation of the mouth, infection of the skin around fingernails or toenails, dry skin, decreased appetite, or itching.

The recommended dose of Gilotrif is 40 mg orally once daily at least 1 hour before or 2 hours after a meal, until the disease progresses or the drug is no longer tolerated. Gilotrif may interact with ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, amiodarone, rifampicin, carbamazepine, phenytoin, phenobarbital, or St. John's wort. Tell your doctor all medications and supplements you use. Gilotrif should not be used during pregnancy. It can harm a fetus. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Gilotrif (afatinib) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Clinical Trials Experience

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in practice.

The safety evaluation of GILOTRIF is based on the data
from more than 3800 patients, including 2135 NSCLC patients receiving GILOTRIF
monotherapy at or above the recommended dose.

Controlled Study

The data in Tables 1 and 2 below reflect exposure of 229
EGFR-TKI naïve GILOTRIF-treated patients with EGFR mutation-positive,
metastatic, non-squamous, NSCLC enrolled in a randomized, multicenter,
open-label trial (Study 1). Patients received GILOTRIF 40 mg daily until
documented disease progression or intolerance to the therapy. A total of 111
patients were treated with pemetrexed/cisplatin. Patients were treated with
pemetrexed 500 mg/m² followed after 30 minutes by cisplatin 75 mg/m² every
three weeks for a maximum of six treatment courses.

The median exposure was 11.0 months for patients treated
with GILOTRIF and 3.4 months for patients treated with pemetrexed/cisplatin.
The overall trial population had a median age of 61 years; 61% of patients in
the GILOTRIF arm and 60% of patients in the pemetrexed/cisplatin arm were
younger than 65 years. A total of 64% of patients on GILOTRIF and 67% of
pemetrexed/cisplatin patients were female. More than two-thirds of patients
were from Asia (GILOTRIF 70%; pemetrexed/cisplatin 72%).

Dose reductions due to adverse reactions were required in
57% of GILOTRIF-treated patients. The most frequent adverse reactions that led
to dose reduction in the patients treated with GILOTRIF were diarrhea (20%),
rash/acne (19%), paronychia (14%), and stomatitis (10%).

Discontinuation of therapy in GILOTRIF-treated patients
for adverse reactions was 14.0%. The most frequent adverse reactions that led
to discontinuation in GILOTRIF-treated patients were diarrhea (1.3%), ILD
(0.9%), and paronychia (0.9%).

Clinical trials of GILOTRIF excluded patients with an
abnormal left ventricular ejection fraction (LVEF), i.e., below the
institutional lower limit of normal. In Study 1, all patients were evaluated
for LVEF at screening and every 9 weeks thereafter in the GILOTRIF-treated
group and as needed in the pemetrexed/cisplatin group. More GILOTRIF-treated
patients (2.2%; n=5) experienced ventricular dysfunction (defined as diastolic
dysfunction, left ventricular dysfunction, or ventricular dilation; all <
Grade 3) compared to chemotherapy-treated patients (0.9%; n=1).